Outcome Study of Restrictive vs. Liberal Intraoperative Fluid Management Guided by PPV in Esophagectomy

Postoperative Lung Function, Kidney Function, Inflammatory Response and Short-term Outcome After Esophagectomy and Reconstruction: Intraoperative Fluid Management Controlled With Lower and Higher Pulse Pressure Variation

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01933451

Acronym

PPV

Enrollment

Registered

2013-09-02

Start date

2013-03-31

Completion date

2013-08-31

Last updated

2013-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Complications of Esophagostomy

Keywords

fluid therapy, Intraoperative care, Patient Outcome Assessment, pulse pressure variation, restrictive fluid therapy, goal-directed fluid therapy, esophagectomy

Brief summary

The purpose of this study is to determine whether intraoperative restrictive fluid management guided by pulse pressure variation produces a better effect on the postoperative lung function, kidney function, inflammatory response and short-term outcome after esophagectomy and reconstruction.

Detailed description

Measurements: intraoperative Lung injury score, Lung water index, Pulmonary vascular Permeability Index Measurements: intraoperative and postoperative Plasma creatine, C reactive protein (CRP), lactate, Neutrophil gelatinase-associated lipocalin (NGAL), Interleukin-6 (IL-6), Interleukin-8 (IL-8)

Interventions

OTHERIntraoperative fluid therapy

Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

* patients undergoing esophagectomy and reconstruction

Exclusion criteria

* ASA score \>= 3, (American Society of Anesthesiologist physical status classification system) * arrythmia, atrial fibrillation * lung diseases, such as COPD (chronic obstructive pulmonary disease); lung function test showed moderate to severe ventilation defect * plasma creatinine level above 1.5 mg/dl

Design outcomes

Primary

Measure	Time frame	Description
postoperative lung function, kidney function, inflammatory response	from introperative to postoperative day 2	plasma creatinine, CRP, lactate, NGAL, IL-6, IL-8

Secondary

Measure	Time frame	Description
postoperative short-term outcome	the duration of hospital stay, about 4 weeks	Respiratory complication, cardiovascular complication, acute renal failure, another complications

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026